VC005 Topical Gel is to Launch Phase III Trials! Jiangsu Vcare’s Fourth Independently Developed Innovative Drug will enter the Confirmatory Clinical Stage

　　Recently, VC005 Topical Gel, a second-generation highly selective JAK1 inhibitor independently developed by Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare), has received ethical approval for its Phase III clinical trial. The Phase III study for the treatment of mild-to-moderate atopic dermatitis (AD) will soon be initiated, marking a pivotal milestone as this differentiated innovative topical drug advances into the confirmatory clinical stage. It is expected to deliver a safer, more effective novel therapeutic option for domestic AD patients. As one of the core products in innovative drug pipeline of Jiangsu Vcare, VC005 Topical Gel is a novel second-generation highly selective JAK1 inhibitor for topical skin exposure. Its Phase II clinical trial for mild-to-moderate AD has achieved positive results, fully validating the product’s favorable efficacy and safety profile.

　　The upcoming initiated Phase III trial adopts a multicenter, randomized, double-blind, vehicle-controlled design. It will be conducted in a larger sample of patients with mild-to-moderate AD to further systematically verify the long-term efficacy and safety of VC005 Topical Gel, yielding robust and compelling clinical data to support subsequent applications of marketing authorization .

　　Currently, Jiangsu Vcare has established a comprehensive R&D matrix covering multiple indications in the field of dermatological autoimmune diseases. The oral tablet formulation of VC005 for AD completed patient enrollment in Phase III last year. With the initiation of Phase III for the topical gel, the product portfolio now covers patients with mild, moderate, and severe AD, consistently delivering more comprehensive and high-quality therapeutic hope to broad patient population.

　　About VC005 Topical Gel

　　VC005 is a novel, potent, and highly selective second-generation JAK1 inhibitor. Both oral and topical formulations with multiple specifications have been developed, forming a product matrix covering multiple therapeutic areas.

　　As a novel JAK1-targeted topical gel for skin exposure, VC005 Topical Gel utilizes a unique pharmaceutical dosage form matrix. While achieving high drug loading, it also features excellent stability, safety, non-irritation, and a refreshing gel texture, greatly improving patient medication compliance.

　　In the completed Phase II clinical trial for mild-to-moderate atopic dermatitis, VC005 Topical Gel demonstrated significant anti-pruritic effects and skin lesion recovery early in treatment: pruritus relief was observed on the first day, with the average Numeric Rating Scale (NRS) for pruritus decreasing by approximately 14% within 12 hours. After one week of administration, at least a 50% improvement in skin lesions (EASI-50 response) was achieved in about 30% of patients, significantly improve their quality of life.

　　In terms of safety, the incidence of treatment-related adverse events (TRAE) was lower than that in the vehicle group, with no serious adverse reactions (SAR) reported, indicating favorable patient tolerability. Regarding metabolism, plasma exposure is extremely low, especially in adolescents, with no drug accumulation. It is expected to address the black box warning issues of marketed topical drugs targeting the same receptor.

　　In February 2026, to accelerate the translation and implementation of innovative achievements, Jiangsu Vcare entered into a strategic R&D cooperation with Beijing Sunshine Nohe Drug Research Co., Ltd. for VC005 Topical Gel (1% specification), collaborating to advance the clinical development of the drug.

　　About Atopic Dermatitis

　　Atopic dermatitis (AD) is a chronic, recurrent, inflammatory skin disease characterized by dry skin, intense pruritus, and eczematous rashes, which severely impacts patients' quality of life. Epidemiologically, the global prevalence of AD is approximately 230 million people. In China, the prevalence of AD among adults ranges from 2% to 8%, with over 70 million patients, including 67% with mild cases and 33% with moderate-to-severe cases. According to F&S forecasts, the number of patients will continue to grow at a compound annual growth rate (CAGR) of 1.7% from 2025 to 2030. Traditional therapeutic drugs, such as glucocorticoids, are associated with numerous adverse reactions and fail to provide long-term benefits, making it difficult to achieve effective and stable disease control. In contrast, topical small-molecule JAK1-targeted inhibitors are non-glucocorticoid immunosuppressants, which are expected to retain therapeutic efficacy with further improvement in the medication safety for patients with mild-to-moderate symptoms.